Neogenix Receives FDA Orphan Drug Status for Ensituximab
The company initiated in December 2009 a multi-center Phase I clinical trial of ensituximab (NPC-1C) for the treatment of advanced pancreatic and colorectal cancer.
Orphan status entitles Neogenix Oncology to seven years of marketing exclusivity for ensituximab (NPC-1C) for the treatment of pancreatic cancer upon regulatory approval, as well as the opportunity to apply for grant funding from the US government to defray costs of clinical trial expenses, tax credits for clinical research expenses and potential exemption from the FDA's application user fee.
The US Orphan Drug Act of 1983 was created to promote the development of new drug therapies for the treatment of diseases that affect fewer than 200,000 individuals in the US.
According to the American Cancer Society (ACS), cancer of the pancreas is the fourth leading cause of cancer-related death overall in the US. The ACS estimates that annual incidence of pancreatic cancer in the US to be greater than 43,000 cases, and more than 36,000 people are expected to die from the disease in 2010.
Philip Arlen, president and CEO of Neogenix Oncology, said: “Receiving orphan drug designation from the FDA is a significant step for Neogenix Oncology in development of ensituximab (NPC-1C).
“With pancreatic cancer awareness month upon us, receiving orphan status underscores the importance of our clinical research goals along with our partners at The Johns Hopkins Hospital, Duke University Medical Center and North Shore LIJ. We are committed to improving treatment options for this deadly disease.”
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